Responsible for executing the Pharmacovigilance compliance oversight process for market research, patient support programs, and non-interventional studies, including fulfilling audit/inspection requests and gathering key performance metrics
Job Summary
Responsible for executing the Pharmacovigilance compliance oversight process for market research, patient support programs, and non-interventional studies, including fulfilling audit/inspection requests and gathering key performance metrics.
Key duties involve reviewing and approving programs within defined systems, making timely decisions to prevent noncompliance, maintaining documentation, and ensuring accurate data for performance and compliance metrics.
Collaborate with key functional partners such as Commercial Activity Owners, International Pharmacovigilance (IPV), and R&D Activity Owners to ensure compliance requirements are met and support the implementation of process efficiencies.
Matching Summary
Responsible for executing the Pharmacovigilance compliance oversight process for market research, patient support programs, and non-interventional studies, including fulfilling audit/inspection requests and gathering key performance metrics.
Skills & Requirements
Must-have
Pharmacovigilance compliance oversight
Market research compliance
Patient support program oversight
Non-interventional study compliance
Data analysis and visualization
Regulatory compliance
Nice-to-have
Continuous improvement initiatives
Process efficiencies
Stakeholder collaboration
Training and guidance
Risk mitigation strategies
Key Requirements
Minimum 2 years pharma or clinical experience
Bachelor’s degree in Science, Engineering, or Technical subjects
Understanding of relevant regulations and industry standards
Ability to manage issues using deductive reasoning